Dimension Vista LOCI CA 15-3 Flex reagent cartridge — Class II medical device recall Z-1648-2022
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2022-09-07, distributed nationwide. Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of del
| Recall number | Z-1648-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2022-07-18 |
| Classified | 2022-08-29 |
| Reported by FDA | 2022-09-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CA, CH, DE, FR, IT |
| Lot numbers | 21340BB, 22049BC, 22112BF |
| Model numbers | 10464344/K6456 |
| Expiration dates | 2022-12-06, 2023-02-18, 2023-04-20 |
Product
Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Siemens Material Number (SMN)/Ref Catalog Number : 10464344/K6456
Reason for recall
Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of delay in appropriate treatment and management decisions.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1648-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.